Amlodipine and atorvastatin

Atorvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Atorvastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).

Amlodipine is a calcium channel blocker. Amlodipine relaxes the blood vessels, improving blood flow and making it easier for the heart to pump.

Amlodipine and atorvastatin is a combination medicine used to treat high blood pressure (hypertension) or chest pain (angina), and to lower the risk of stroke, heart attack, and other heart complications in people with type 2 diabetes, coronary heart disease, or other risk factors.

Amlodipine and atorvastatin is used in adults and children who are at least 10 years old.

Amlodipine and atorvastatin may also be used for purposes not listed in this medication guide.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives
• itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash
• tightness in the chest
• unusual tiredness or weakness
• wheezing

• Chest pain or discomfort
• dilated neck veins
• extra heartbeats
• extreme fatigue
• irregular breathing
• irregular heartbeat
• pulse irregularity
• swelling of the face, fingers, feet, or lower legs
• weight gain

• Blistering, peeling, or loosening of the skin
• chills
• dark-colored urine
• diarrhea
• fever
• joint or muscle pain
• muscle cramps or spasms
• muscle stiffness
• red, irritated eyes
• red skin lesions, often with a purple center
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips

Get emergency help immediately if any of the following symptoms of overdose occur:

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• feeling of warmth
• redness of the face, neck, arms, and occasionally, upper chest
• sweating

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Body aches or pain
• congestion
• difficulty with moving
• headache
• lower back or side pain
• pain or tenderness around the eyes and cheekbones
• painful or difficult urination
• runny or stuffy nose
• tender, swollen glands in the neck
• voice changes

• Accidental injury
• acid or sour stomach
• belching
• bloated or full feeling
• difficulty having a bowel movement (stool)
• excess air or gas in the stomach or intestines
• general feeling of discomfort or illness
• heartburn
• indigestion
• lack or loss of strength
• loss of appetite
• nausea
• passing gas
• shivering
• sleepiness or unusual drowsiness
• stomach discomfort, upset, or pain
• trouble sleeping
• vomiting

• Anxiety
• bad, unusual, or unpleasant (after) taste
• blistering, crusting, irritation, itching, or reddening of the skin
• burning feeling in the chest or stomach
• burning while urinating
• change in near or distance vision
• change in taste
• change in the color of the skin
• cold and clammy skin
• cracked, dry, scaly skin
• difficulty in focusing eyes
• dry mouth
• dryness of the eyes
• excessive muscle tone
• frequent urination
• hair loss or thinning of the hair
• increased appetite
• increased volume of pale, dilute urine
• irritability
• lack of feeling or emotion
• loose stools
• loss of memory
• muscle tension or tightness
• muscle weakness
• problems with memory
• restlessness
• severe and throbbing headache
• shakiness and unsteady walk
• sneezing
• tenderness in the stomach area
• transient, mild, or pleasant aromatic odor
• trembling, or other problems with muscle control or coordination
• twitching
• uncaring
• unsteadiness
• welts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Use amlodipine and atorvastatin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Swallow whole. Do not chew, break, or crush.
• If you have trouble swallowing, talk with your doctor.
• Take this medicine at the same time of day.
• To gain the most benefit, do not miss doses.
• Keep taking amlodipine and atorvastatin as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is less than 12 hours until the next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Joint pain.
• Loose stools (diarrhea).
• Dizziness.
• Upset stomach.
• Nose or throat irritation.
• Feeling tired or weak.
• Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

For use when treatment with both amlodipine and atorvastatin is appropriate:

Amlodipine: Treatment of hypertension; treatment of chronic stable angina, vasospastic (Prinzmetal's) angina (confirmed or suspected); prevention of hospitalization or to decrease coronary revascularization procedure due to angina with documented CAD (limited to patients without heart failure or ejection fraction <40%)

Atorvastatin: Treatment of dyslipidemias or primary prevention of cardiovascular disease (atherosclerotic) as detailed here:

Primary prevention of cardiovascular disease (high-risk for CVD): To reduce the risk of MI or stroke in patients without evidence of coronary heart disease who have multiple CVD risk factors or type 2 diabetes; also reduces the risk for angina or revascularization procedures in patients with multiple CVD risk factors without evidence of coronary heart disease

Secondary prevention of cardiovascular disease: To reduce the risk of MI, stroke, revascularization procedures, angina, and hospitalization for heart failure

Primary and secondary prevention of atherosclerotic cardiovascular disease (ASCVD) according to the American College of Cardiology/American Heart Association: To reduce the risk of ASCVD in patients with clinical ASCVD (eg, coronary heart disease, stroke/TIA, or peripheral arterial disease presumed to be of atherosclerotic origin); in patients without clinical ASCVD if LDL-C is 190 mg/dL or greater; in patients without clinical ASCVD who have type 1 or type 2 diabetes and are between 40 and 75 years of age; in patients with an estimated 10-year ASCVD risk 7.5% or greater and who are between 40 and 75 years of age (Stone, 2013). Specific recommendations from the Kidney Disease: Improving Global Outcomes (KDIGO) organization have also been released for patients with chronic kidney disease (KDIGO [Tonelli, 2013]).

Treatment of dyslipidemias: To reduce elevations in total cholesterol, LDL-C, apolipoprotein B, and triglycerides in patients with elevations of one or more components, and/or to increase low HDL-C as present in heterozygous familial/nonfamilial hypercholesterolemia and mixed dyslipidemia (Fredrickson type IIa and IIb hyperlipidemias); treatment of primary dysbetalipoproteinemia (Fredrickson type III), elevated serum TG levels (Fredrickson type IV), and homozygous familial hypercholesterolemia

Treatment of heterozygous familial hypercholesterolemia (HeFH) in adolescent patients (10 to 17 years of age, females >1 year postmenarche) having LDL-C ≥190 mg/dL or LDL-C ≥160 mg/dL with positive family history of premature cardiovascular disease (CVD) or with two or more CVD risk factors.

Amlodipine: Blood pressure

Atorvastatin:

2013 ACC/AHA Blood Cholesterol Guideline recommendations (Stone, 2013):

Lipid panel (total cholesterol, HDL, LDL, triglycerides): Baseline lipid panel; fasting lipid profile within 4 to 12 weeks after initiation or dose adjustment and every 3 to 12 months (as clinically indicated) thereafter. If 2 consecutive LDL levels are <40 mg/dL, consider decreasing the dose.

Hepatic transaminase levels: Baseline measurement of hepatic transaminase levels (ie, ALT); measure hepatic function if symptoms suggest hepatotoxicity (eg, unusual fatigue or weakness, loss of appetite, abdominal pain, dark-colored urine or yellowing of skin or sclera) during therapy.

CPK: CPK should not be routinely measured. Baseline CPK measurement is reasonable for some individuals (eg, family history of statin intolerance or muscle disease, clinical presentation, concomitant drug therapy that may increase risk of myopathy). May measure CPK in any patient with symptoms suggestive of myopathy (pain, tenderness, stiffness, cramping, weakness, or generalized fatigue).

Evaluate for new-onset diabetes mellitus during therapy; if diabetes develops, continue statin therapy and encourage adherence to a heart-healthy diet, physical activity, a healthy body weight, and tobacco cessation.

If patient develops a confusional state or memory impairment, may evaluate patient for nonstatin causes (eg, exposure to other drugs), systemic and neuropsychiatric causes, and the possibility of adverse effects associated with statin therapy.

Manufacturer’s labeling: Baseline liver function tests and repeat when clinically indicated thereafter. Upon initiation or titration, lipid panel should be analyzed within 2 to 4 weeks.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, joint pain, nausea, rhinitis, loss of strength and energy, pharyngitis, or insomnia. Have patient report immediately to prescriber severe dizziness, passing out, shortness of breath, excessive weight gain, swelling of arms or legs, angina, tachycardia, abnormal heartbeat, memory impairment, muscle pain, muscle weakness, muscle rigidity, tremors, abnormal movements, urinary retention, change in amount of urine passed, signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), or signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Applies to amlodipine / atorvastatin: oral tablet

Along with its needed effects, amlodipine / atorvastatin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking amlodipine / atorvastatin:

• Cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives
• itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash
• tightness in the chest
• unusual tiredness or weakness
• wheezing

• Chest pain or discomfort
• dilated neck veins
• extra heartbeats
• extreme fatigue
• irregular breathing
• irregular heartbeat
• pulse irregularity
• swelling of the face, fingers, feet, or lower legs
• weight gain

• Blistering, peeling, or loosening of the skin
• chills
• dark-colored urine
• diarrhea
• fever
• joint or muscle pain
• muscle cramps or spasms
• muscle stiffness
• red, irritated eyes
• red skin lesions, often with a purple center
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips

Get emergency help immediately if any of the following symptoms of overdose occur while taking amlodipine / atorvastatin:

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• feeling of warmth
• redness of the face, neck, arms, and occasionally, upper chest
• sweating

Some side effects of amlodipine / atorvastatin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Body aches or pain
• congestion
• difficulty with moving
• headache
• lower back or side pain
• pain or tenderness around the eyes and cheekbones
• painful or difficult urination
• runny or stuffy nose
• tender, swollen glands in the neck
• voice changes

• Accidental injury
• acid or sour stomach
• belching
• bloated or full feeling
• difficulty having a bowel movement (stool)
• excess air or gas in the stomach or intestines
• general feeling of discomfort or illness
• heartburn
• indigestion
• lack or loss of strength
• loss of appetite
• nausea
• passing gas
• shivering
• sleepiness or unusual drowsiness
• stomach discomfort, upset, or pain
• trouble sleeping
• vomiting

• Anxiety
• bad, unusual, or unpleasant (after) taste
• blistering, crusting, irritation, itching, or reddening of the skin
• burning feeling in the chest or stomach
• burning while urinating
• change in near or distance vision
• change in taste
• change in the color of the skin
• cold and clammy skin
• cracked, dry, scaly skin
• difficulty in focusing eyes
• dry mouth
• dryness of the eyes
• excessive muscle tone
• frequent urination
• hair loss or thinning of the hair
• increased appetite
• increased volume of pale, dilute urine
• irritability
• lack of feeling or emotion
• loose stools
• loss of memory
• muscle tension or tightness
• muscle weakness
• problems with memory
• restlessness
• severe and throbbing headache
• shakiness and unsteady walk
• sneezing
• tenderness in the stomach area
• transient, mild, or pleasant aromatic odor
• trembling, or other problems with muscle control or coordination
• twitching
• uncaring
• unsteadiness
• welts

Data not available